MAUDE Adverse Event Report: ETHICON INC. SFX SPI MCRYL+ UNI 12IN 3-0 SA PS-1 PRM MP; SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID

Model Number	SXMP1B101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Pocket Erosion (2013)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a c-section on (b)(6) 2022 and a barbed suture was used for skin closure.The patient went in for their post-op 6 week check up and the suture had migrated.The suture was 5 cm laterally from the pfannenstiel incision towards the umbilicus.The patient had pain.It was reported that a further procedure is not being performed as the sutures will absorb.It was stated that no change had been made to technique.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 2360 g/m.(b)(4).Attempts are being made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please provide the patient's demographic information including age, weight, bmi at the time of index procedure.What is the date of the procedure? what was the tissue condition (normal, thin, calcified, fragile, diseased)? please describe the exact anchoring at the beginning and end of the incision.For the stratafix symmetic suture, was the fixation tab seated against the tissue at the initiation of suture use during the index procedure? for the stratafix symmetic suture, were two reverse stitches performed across the incision prior to closure? for each of the stratafix spiral sutures, was the fixation loop secured to tissue at the initiation of suture use during the index procedure? for each of the stratafix spiral sutures, was at least one reverse stitch performed prior to closure? which suture migrated? please specify which product code.How was the migrated suture identified? on what date was the migrated suture identified? was there any allegation of post-op suture breakage? please describe any medical/surgical intervention required for this suture event including dates and results.If the patient underwent a re-operation, can you describe the appearance of the stratafix suture? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? please provide the onset date/time of pain from the initial procedure (# of post-operative days).Location and character of pain? is there any specific activity that precipitated the pain or eased the pain? please describe any medical intervention given for pain management including medication name and results.Other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? lot numbers of the 3 sutures, if available? if applicable, will product be returned? if so, please provide the return date and tracking information.Note: events reported via 2210968-2022-06068, 2210968-2022-06069.

• Brand Name: SFX SPI MCRYL+ UNI 12IN 3-0 SA PS-1 PRM MP
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15128671
• Report Number: 2210968-2022-06070
• Device Sequence Number: 14814381
• Product Code: GAM
• UDI-Device Identifier: 10705031236776
• UDI-Public: 10705031236776
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• PMA/510(K) Number: N12159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SXMP1B101
• Device Catalogue Number: SXMP1B101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female